FDA Logo links to FDA home page
Center for Biologics Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Biologics Evaluation and Research
 HHS Logo links to Department of Health and Human Services website

FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

horizontal rule
CBER links to product areas Blood Vaccines Cellular/Gene Therapy Tissue Devices
CBER links Products Industry Healthcare Reading Room Meetings What's New
horizontal rule

Recall of Albumin (Human) 25%, Albuminar
ZLB Behring LLC

horizontal rule

DATE RECALL INITIATED:

    August 29, 2005

PRODUCT:

    Albumin (Human) 25%, Albuminar, 100 mL

    C934009     9/16/2007
    C934110     10/5/2007

MANUFACTURER:

    ZLB Behring L.L.C.
    King of Prussia, PA

REASON:

    Lots C934009 and C934110 are being recalled as a precautionary measure. One bottle of Albuminar in Japan has been found with a stopper defect that may allow product leakage. The same stopper batch as that used in Japan was also used on these two lots. As of this date, there are no technical complaints or adverse events reported against either lot. The firm is requesting that the use of these lots be immediately discontinued and that the product be returned to the manufacturer for credit.

Updated information

horizontal rule

The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

 

 
horizontal rule